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« Conference & CLE Calendar | Main | Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver »

May 09, 2021

Comments

“It is unlikely that most of the countries in favor of the waiver (except India and South Africa) have the technological infrastructure for producing the vaccine.”

It is unlikely that even India & South Africa have the technological infrastructure necessary to produce any of the approved COVID vaccines. Just because one has the machinery necessary to produce *some* vaccines does not mean that one has the machinery necessary to produce *these* vaccines. None of them—neither the mRNA vaccines of Pfizer & Moderna nor the adenoviral vectors of J&J & AstraZeneca—are like *any* other vaccines that has ever been approved for human use. IN & ZA have infrastructure for making MMR, or DTAP, or seasonal flu vaccines, but the various approved COVID-19 vaccines are different kettles of fish entirely.

I don't think the mooted waiver has anything to do with compelling WTO members to suspend any patent enforcement rights within their territory, much less to force any company to divulge trade secrets.

What TRIPS does is to set minimum standards for protection of IP rights by member states. Failure to meet those minimum standards exposes a country to formal complaints by other members, and potential sanctions. A waiver would make sanctions unavailable in respect of failure to protect IP rights falling within whatever parameters are agreed through negotiations.

This would presumably mean that countries such as India and South Africa could authorise manufacturers to produce COVID vaccines regardless of the existence of relevant patent rights, and bar the patentees from enforcing those rights.

Of course, they can do this without a waiver, via compulsory licensing provisions (that are permitted under TRIPS). Chile and Israel have already done so. But perhaps the terms of a waiver would free them from the obligation to compensate the patentees, making the process simpler and cheaper.

You also have to wonder whether any country would pursue sanctions against a poorer nation for manufacturing COVID vaccines in breach of patent rights during the pandemic. It doesn't seem very likely.

So is all the talk about waivers just a lot of hot air, lobbying by the usual anti-patent suspects, and/or "virtue signalling" by some nations and organisations that have come out in support? Who knows...

For those interested to published patent applications and granted patents already disclosing technical information about Covid-19 vaccines and anti-Sars-Cov-2 antibodies, I will make a presentation at PIUG2021 on May 27th.

If the patents are not limiting vaccine R&D, clinical trials, or production, then the waiver is harmless unless and until they do so. (Compare Pfizer's unauthorized use of mNeon Green, which didn't stop Pfizer from using it and now they are just opposing compensation to the patent holder.) So it seems like the opposition to the patent waiver is misguided and unduly strident. Particularly as the waivers do not disclose anything that is not already public. (Whether they should disclose sufficient information for at-scale production is a discussion for a different day.) And since trade secret waivers (actually compelled transfers) would likely be considered a taking that requires compensation, (see Monsanto v Ruckelshaus) again it seems like the opposition is unjustified and unduly strident. Unless the point of opposing the waiver is precisely to prevent manufacturing scale-up of needed vaccines, as opposed to uncompensated scale-up. Similarly, objections about liability for inadequate production seem wholly unjustified, as any such compelled transfers will not create any liability for the current trade secret holders, and in any event that is what we have regulatory authorities for which to assure safe production.

If the government funded the research and development of these vaccines, the public should have a say in how the vaccines are made and distributed, including something like compulsory licensing, which many other countries have. In situations like this pandemic, having numerous producers will be helpful. Even if trade secrets are needed to make a particular vaccine, sharing those secrets with IN or ZA, or other capable manufacturers’s countries serve the public.

Herd immunity cannot be created on a country-by country basis. World-wide immunity is required.

Josh: on one level you are correct, that this may have no practical effect depending on how it is implemented. Philosophically it is problematic to abandon time-tested working IP principles based on panic, for a policy that won’t actually improve global vaccine accessibility.

But the point here is choice: the innovators disclosed their trade secrets to government regulators under a promise that the government would not give their technology away. There may be no measure on compensation sufficient to permit competitors in future from using this technology for more than just COVID; once the genie is out of the bottle it won’t go back in.

And as a consequence once again the government’s actions are incentivizing behavior that hides the “secret sauce” of how inventions are made, the antithesis of the disclosure intention of the patent system.

There are ways to produce and deliver the ~6-7 billion doses needed for global vaccination. Not only is this not one of them but it promises to make addressing effectively the next pandemic harder and less likely.

Well, Ben, if the government invested $1 million, and the companies expended $1 billion, do you still feel the same way?

Mark Summerfield's comment about Israel exercising compulsory licensing provisions in its patent statute is misleading, in that his statement implies that Israel exercised these provisions with respect to a vaccine. That's not the case; Israel paid a premium for Pfizer vaccines (about $30/dose), and Pfizer benefited handsomely from the data obtained by what was effectively a huge-scale trial using millions of patients. Additionally, as far as I know, there are no patents in Israel that specifically cover the Pfizer vaccine. There are several pending BioNTech patent applications that might cover the vaccine, but of course "pending" is not "granted".

The compulsory licensing in question concerned Abbvie's drug Kaletra, which was identified in early 2020 as a possible treatment for COVID-19. In the end (a) Abbvie offered to make it available to all countries, and (b) it wasn't adopted as a therapy. Moreover, it was well-understood by the Israel government lawyers that Abbvie would need to be fairly compensated. I blogged about these issues at the time here:
https://www.iliplaw.com/americaisrael_patent_law/2020/03/israel-makes-first-use-of-statutory-provision-allowing-patent-infringement-by-state.html
and here:
https://www.iliplaw.com/americaisrael_patent_law/2020/03/a-few-more-thoughts-on-israels-exercising-its-right-to-exploit-abbvies-patents.html
and here:
https://www.iliplaw.com/americaisrael_patent_law/2020/03/abbvie-to-suspend-enforcement-of-kaletra-patents-maybe-probably-unrelated-to-israel.html

Thanks, Dan, for the clarification

Kevin, it is highly unlikely that any company can "hide the secret sauce" in the future, if disclosing it is a condition of regulatory marketing approval. The concern about inadequate compensation exists, but it would be no less a concern for a compulsory license, which is fully legal. We just don't usually order compulsory licenses of trade secrets, only of patent rights. And no doubt you or someone else could litigate very well the reasonably expected value of the loss of trade secrecy. Which is a win for lawyers, as well as the public (which does not necessarily exclude lawyers). Josh

Three different angles:

Has not been done.

Cannot be done.

Should not be done.

For some reason, certain folks still seem to be confusing these things.

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